Company ยท US
Orbus Medical Technologies
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2004. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 2004 | K041370 | LIFESTENT LP SDS BILIARY ENDOPROSTHESIS Orbus Medical Technologies | FGE |
| May 10, 2004 | K041032 | MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS Orbus Medical Technologies | FGE |
| Mar 16, 2004 | K040550 | LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS Orbus Medical Technologies | FGE |
| Oct 30, 2003 | K033212 | LIFESTENT SDS BILIARY ENDOPROSTHESIS Orbus Medical Technologies | FGE |
| Apr 14, 2003 | K023308 | LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS Orbus Medical Technologies | FGE |
| Mar 10, 2003 | K023121 | LIFESTENT BILIARY ENDOPROSTHESIS Orbus Medical Technologies | FGE |
| Feb 11, 2003 | K023248 | LIFESTENT LP SDS BILIARY ENDOPROSTHESIS Orbus Medical Technologies | FGE |
| Jul 31, 2001 | K010107 | R STENT BILIARY ENDOPROSTHESIS Orbus Medical Technologies | FGE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Orbus Medical Technologies Inc The product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree.
The product is labeled as Edwa Terminated |
MEW | K023248 |